Medical grafting methods and apparatus

ABSTRACT

Methods and apparatus for delivering and installing a new length of tubing between two sections of a patient&#39;s existing body organ tubing and at least partly outside of that existing structure. For example, the new length of tubing may be for the purpose of providing the patient with a coronary bypass. The new tubing may be an artificial graft, a natural graft (harvested elsewhere from the patient), or both. The new tubing is delivered to and installed at the operative site primarily by working through the patient&#39;s existing tubular body organ structure. This avoids the need for any significant surgery on the patient.

[0001] This is a division of U.S. patent application Ser. No.09/712,968, filed Nov. 15, 2000, which is a continuation of U.S. patentapplication Ser. No. 09/287,941, filed Apr. 7, 1999 (now U.S. Pat. No.6,186,942), which is a continuation of U.S. patent application Ser. No.08/844,992, filed Apr. 23, 1997 (now U.S. Pat. No. 6,120,432). All ofthese prior applications are hereby incorporated by reference herein intheir entireties.

BACKGROUND OF THE INVENTION

[0002] This invention relates to medical grafting methods and apparatus,and more particularly to methods and apparatus for installing tubularbypass grafts intralumenally.

[0003] Goldsteen et al. U.S. Pat. No. 5,976,178 shows, among otherthings, methods and apparatus for installing tubular bypass graftsintralumenally. (The Goldsteen et al. reference is hereby incorporatedby reference herein in its entirety.) The Goldsteen et al. referenceshows methods and apparatus in which each end of the graft site isapproached separately and intralumenally, penetrated, and then alongitudinal structure (e.g., element 150 in the Goldsteen et al.reference) is established between the ends of the graft site. Thislongitudinal structure may extend intralumenally all the way out of thepatient's body from both ends of the graft site. The graft is fed intothe patient's body intralumenally along the longitudinal structure untilit is in the desired position extending from one end of the graft siteto the other. Each end of the graft is then secured at respective end ofthe graft site and the longitudinal structure is withdrawn from thepatient.

[0004] It may not be necessary or desirable in some cases to separatelyapproach both ends of the graft site.

[0005] It is therefore an object of this invention to provide improvedmethods and apparatus for intralumenal installation of bypass grafts.

[0006] It is a more particular object of this invention to providemethods and apparatus for intralumenally installing bypass grafts whichdo not require both ends of the graft site to be separately approachedintralumenally.

SUMMARY OF THE INVENTION

[0007] These and other objects of the invention are accomplished inaccordance with the principles of the invention by providing methods andapparatus for allowing a longitudinal structure to be extendedintralumenally to one end of a graft site. At that end of the graft sitethe longitudinal structure passes out of the body structure lumen andextends extralumenally to the other end of the graft site. At the otherend of the graft site, the longitudinal structure re-enters the bodystructure lumen. The graft is introduced intralumenally along thelongitudinal structure until it passes out of the body structure lumenat the first end of the graft site and extends to the second end of thegraft site. Both ends of the graft are then secured at the respectiveopposite ends of the graft site, and the longitudinal structure isaxially withdrawn from the patient.

[0008] Further features of the invention, its nature and variousadvantages will be more apparent from the accompanying drawings and thefollowing detailed description of the preferred embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

[0009]FIG. 1 is a simplified sectional view showing a portion of anillustrative procedure and related apparatus in accordance with thisinvention.

[0010]FIG. 2 is a simplified longitudinal sectional view of anillustrative embodiment of a portion of the FIG. 1 apparatus in moredetail.

[0011]FIG. 3 is a simplified elevational view of a portion of the FIG. 2apparatus, but with the depicted elements in a different physicalrelationship to one another.

[0012]FIG. 4 is a simplified longitudinal sectional view of analternative embodiment of one component of the FIG. 2 apparatus.

[0013]FIG. 5 is a simplified longitudinal sectional view of analternative embodiment of another component of the FIG. 2 apparatus.

[0014]FIG. 6 is a simplified elevational view of another alternativeembodiment of the component shown in FIG. 5.

[0015]FIG. 7 is a simplified elevational view of an alternativeembodiment of still another component shown in FIG. 2.

[0016]FIG. 8 is a simplified elevational view of an alternativeembodiment of yet another component shown in FIG. 2.

[0017]FIG. 9 is a simplified longitudinal sectional view similar to aportion of FIG. 1 showing a later stage in the illustrative proceduredepicted in part by FIG. 1.

[0018]FIG. 10 is a simplified sectional view of the apparatus shown inFIG. 9 without the associated tissue structure being present.

[0019]FIG. 11 is a simplified cross sectional view of an illustrativeembodiment of further illustrative apparatus in accordance with thisinvention.

[0020]FIG. 12 is a view similar to FIG. 1 showing an even later stage inthe illustrative procedure depicted in part by FIG. 9, together withrelated apparatus, all in accordance with this invention.

[0021]FIG. 13 is a view similar to FIG. 12 showing a still later stagein the illustrative procedure depicted in part by FIG. 12.

[0022]FIG. 13a is a simplified elevational view of an illustrativeembodiment of structural details that can be included in apparatus ofthe type shown in FIGS. 11-13.

[0023]FIG. 14 is a view similar to FIG. 13 showing an even later stagein the illustrative procedure depicted in part by FIG. 13.

[0024]FIG. 15 is a simplified longitudinal sectional view of anillustrative embodiment of a portion of still further illustrativeapparatus in accordance with this invention.

[0025]FIG. 15a is a simplified elevational view of a structure which canbe used to provide part of the apparatus shown in FIG. 15.

[0026]FIG. 15b is a view similar to FIG. 15a showing more of thestructure of which FIG. 15a is a part.

[0027]FIG. 15c is a view similar to FIG. 15b showing the FIG. 15bstructure in another operational condition.

[0028]FIG. 15d is a simplified elevational view of an alternativestructure which can be used to provide part of the apparatus shown inFIG. 15.

[0029]FIG. 15e is a view similar to FIG. 15d showing the FIG. 15dstructure in another operational condition.

[0030]FIG. 15f is a simplified longitudinal sectional view of anotheralternative structure which can be used to provide part of the apparatusshown in FIG. 15.

[0031]FIG. 15g is a view similar to FIG. 15f showing the FIG. 15fstructure in another operational condition.

[0032]FIG. 16 is a simplified elevational view of an illustrativeembodiment of one component of the FIG. 15 apparatus.

[0033]FIG. 17 is a simplified longitudinal sectional view of anillustrative embodiment of another portion of the FIG. 15 apparatus.

[0034]FIG. 18 is a view similar to a portion of FIG. 14 showing an evenlater stage in the illustrative procedure depicted in part by FIG. 14.

[0035]FIG. 19 is a view similar to FIG. 18 showing a still later stagein the FIG. 18 procedure.

[0036]FIG. 20 is a view similar to FIG. 19 showing an even later stagein the FIG. 19 procedure.

[0037]FIG. 21 is a view similar to another portion of FIG. 14 showing astill later stage in the FIG. 20 procedure.

[0038]FIG. 22 is a view similar to FIG. 21 showing an even later stagein the FIG. 21 procedure.

[0039]FIG. 22a is a view similar to FIG. 22 showing a still later stagein the FIG. 22 procedure.

[0040]FIG. 22b is a view similar to FIG. 22a showing an even later stagein the FIG. 22a procedure.

[0041]FIG. 23 is a view similar to FIG. 22b showing a still later stagein the FIG. 22b procedure.

[0042]FIG. 24 is a view similar to FIG. 23 showing an even later stagein the FIG. 23 procedure.

[0043]FIG. 25 is a simplified longitudinal sectional view of anillustrative embodiment of a portion of more apparatus in accordancewith this invention.

[0044]FIG. 26 is a view similar to FIG. 20 showing a later stage in theFIG. 24 procedure.

[0045]FIG. 27 is a view similar to FIG. 26 showing a still later stagein the FIG. 26 procedure.

[0046]FIG. 28 is a view similar to FIG. 24 showing an even later stagein the FIG. 27 procedure.

[0047]FIG. 29 is a view similar to FIG. 28 showing a still later stagein the FIG. 28 procedure.

[0048]FIG. 30 is a view similar to FIG. 29 showing an even later stagein the FIG. 29 procedure.

[0049]FIG. 31 is a view similar to FIG. 14 showing the end result of theprocedure depicted in part by FIG. 30.

[0050]FIG. 32 is a simplified longitudinal sectional view showing an endresult similar to FIG. 31 but in a different context.

[0051]FIG. 33 is a simplified longitudinal sectional view showing apossible alternative construction of portions of the apparatus showingin FIG. 15.

[0052]FIG. 34 is a simplified elevational view (partly in section)showing another possible alternative construction of portions of theFIG. 15 apparatus.

[0053]FIG. 35 is a simplified longitudinal sectional view of the FIG. 34apparatus in another operating condition.

[0054]FIG. 36 is a simplified elevational view of apparatus which can beused as an alternative to certain apparatus components shown in FIGS. 15and 17.

[0055]FIG. 37 is a simplified elevational view (partly in section)showing additional components with the FIG. 36 apparatus.

[0056]FIG. 38 is a simplified longitudinal sectional view showing stillanother possible alternative construction of portions of the FIG. 15apparatus.

[0057]FIG. 39 is a simplified elevational view showing in more detail apossible construction of a portion of the FIG. 38 apparatus.

[0058]FIG. 40 is a simplified elevational view of illustrative apparatusthat can be used as an alternative to certain apparatus shown in otherFIGS.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0059] A typical use of this invention is to provide a bypass graftaround a narrowing in a coronary artery. Thus FIG. 1 shows a patient'saorta 30 with a coronary artery 20 branching off from the aorta. Anarrowing 22 in coronary artery 20 is obstructing blood flow from aorta30 to downstream portions of the coronary artery, thereby preventing thepatient's heart from receiving all the blood it needs for normaloperation. To remedy this condition, a bypass graft around narrowing 22is needed, and one way to provide such a bypass is to add a graftconduit from aorta 30 (e.g., at location 34) to a downstream portion ofcoronary artery 20 (e.g., at location 24).

[0060] In order to provide such a graft conduit in accordance with thisinvention, elongated instrumentation 200 is introduced into thepatient's circulatory system, preferably from a location remote fromaorta 30. For example, instrumentation 200 may be introduced into thepatient's circulatory system from a femoral artery, a brachial artery,or any other suitable location. From the insertion point instrumentation200 passes intralumenally along the patient's circulatory system until adistal portion 204 of instrumentation 200 is adjacent one end (e.g., 34)of the desired graft site. Undepicted proximal portions ofinstrumentation 200 always remain outside the patient adjacent the pointof introduction of the instrumentation so that the physician (a termwhich includes any technicians or other assistants) can control theinstrumentation from outside the patient's body. In particular, thedepicted distal portions of instrumentation 200 are controlled remotelyby the physician from outside the patient. Radiologic markers such as206 may be provided on instrumentation 200 to aid the physician inproperly locating the instrumentation in the patient.

[0061] It will be understood that the particular location 34 shown inFIG. 1 for one end of the bypass graft is only illustrative, and thatany other suitable location may be chosen instead.

[0062] An illustrative construction of instrumentation 200 is shown inmore detail in FIG. 2. This FIG. shows the distal portions of elements220, 230, 240, and 250 telescoped out from one another and from thedistal end of outer member 210 for greater clarity. It will beunderstood, however, that all of these elements are initially inside ofone another and inside outer member 210. Indeed, member 210 may beinitially positioned in the patient without any or all of elements 220,230, 240, and 250 inside, and these elements may then be inserted intomember 210. Moreover, the number of members like 220, 230, etc., may bemore or less than the number shown in FIG. 2, depending on therequirements of a particular procedure.

[0063] Outer member 210 may be a catheter-type member. The distalportion of catheter 210 may carry two axially spaced annular balloons212 and 214. Proximal balloon 212 is inflatable and deflatable viainflation lumen 216 in catheter 210. Distal balloon 214 is inflatableand deflatable via inflation lumen 218 in catheter 210. Lumens 216 and218 are separate from one another so that balloons 212 and 214 can beseparately controlled. Balloons 212 and 214 are shown substantiallydeflated in FIG. 2. The distal end of catheter 210 may be tapered asshown at 211 in FIG. 4 to facilitate passage of catheter 210 through anaperture in aorta 30 as will be described below.

[0064] Coaxially inside catheter 210 is tubular sheath member 220.Sheath 220 is longitudinally movable relative to catheter 210. Thedistal portion of sheath 220 may be tapered as shown at 222 in FIG. 5,and/or externally threaded as shown at 224 in FIG. 6. Either or both offeatures 222 and 224 may be provided to facilitate passage of sheath 220through an aperture in aorta 30 as will be described below. If threads224 are provided, then sheath 220 is rotatable (either alone or withother components) about the longitudinal axis of instrument 200 in orderto enable threads 224 to engage the tissue of the aorta wall and helppull sheath 220 through the aorta wall.

[0065] Coaxially inside sheath member 220 is power steering tube 230.Tube 230 is longitudinally movable relative to sheath 220. Tube 230 mayalso be rotatable (about the central longitudinal axis of instrument200) relative to sheath 220, and the distal end of tube 230 may bethreaded on the outside (as shown at 232 in FIG. 7) for reasons similarto those for which threading 224 may be provided on sheath 220. Tube 230is preferably controllable from its proximal portion (outside thepatient) to deflect laterally by a desired amount to help steer, push,or twist instrument 200 to the desired location in the patient. Examplesof illustrative steering techniques are discussed in more detail belowin connection with FIGS. 11-13.

[0066] Coaxially inside tube 230 is tube 240. Tube 240 is longitudinallymovable relative to tube 230, and may be metal (e.g., stainless steel)hypotube, for example. Screw head 242 is mounted on the distal end oftube 240 and is threaded (as indicated at 244) on its distal conicalsurface. Tube 240 is rotatable (about the central longitudinal axis ofinstrument 200, either alone or with other elements) in order rotatehead 242 and thereby use threads 244 in engagement with the tissue ofthe aorta wall to help pull head 242 through that wall as will be morefully described below. Because tube 240 is hollow, it can be used forpassage of fluid or pressure into or out of the patient.

[0067] Coaxially inside tube 240 is longitudinal structure 250.Longitudinal structure 250 is longitudinally movable relative to tube240. Structure 250 may also be rotatable (about its longitudinal axis)relative to tube 240 and/or other elements. Structure 250 may be a wirewith a distal end portion 252 that is resiliently biased to deflectlaterally to one side. Wire portion 252 is kept relatively straight whenit is inside tube 240 as shown in FIG. 2. But when wire portion 252 ispushed axially out the distal end of tube 240, it curves to one side asshown in FIG. 3. As an alternative or addition to the above-describedresilient lateral deflection, the distal portion of structure 250 may bethreaded as shown at 254 in FIG. 8 to help structure 250 thread its waythrough the wall of aorta 30.

[0068] All of components 210, 220, 230, 240, and 250 are controlled fromoutside the patient's body as is described in general terms above.

[0069] When the distal portion of catheter 210 is at the desiredlocation 34, proximal balloon 212 is inflated. Even when inflated,proximal balloon 212 is not large enough to block aorta 30.

[0070] After proximal balloon 212 has been inflated, wire 250 is pusheddistally so that its distal portion emerges from the distal end of tube240 and penetrates the wall of aorta 30 at location 34. This anchors thedistal portion of instrument 200 to the aorta wall at the desiredlocation. Because of its operation to thus anchor instrument 200, wire250 is sometimes referred to as an anchor wire. The rotatability of wire250, as well as its resilient lateral deflection (FIG. 3) and/or threads254 (FIG. 8), may be used to help get the distal end of the wire to thedesired location 34 and firmly into the aorta wall at that location inorder to achieve the desired anchoring of instrument 200.

[0071] When instrument 200 is sufficiently anchored by wire 250, tubes230 and 240 are moved in the distal direction relative to wire 250 sothat screw head 242 begins to follow wire 250 into and through the aortawall. During this motion, at least tube 240 is rotated about itslongitudinal axis so that threads 244 help to pull head 242 into andthrough the aorta wall. The distal portion of tube 230 follows head 242through the aorta wall. If provided, threads 232 and rotation of tube230 may facilitate transfer of the aorta wall tissue from head 242 totube 230.

[0072] When tube 230 is through the aorta wall, sheath 220 is moveddistally relative to tube 230 so that a distal portion of sheath 220follows tube 230 through the aorta wall. If provided, the distal taper222 and/or threads 224 and rotation of sheath 220 help the distalportion of sheath 220 through the aorta wall. Then catheter 210 isadvanced distally relative to sheath 220 so that a distal portion ofcatheter 210 follows sheath 220 through the aorta wall. Again, thedistal taper 211 of catheter 210 (if provided) helps the distal portionof the catheter through the aorta wall. Inflated proximal balloon 212prevents more than just the portion of catheter 210 that is distal ofballoon 212 from passing through the aorta wall.

[0073] It should be mentioned that each time another, larger one ofelements 240, 230, 220, and 210 is pushed through the aorta wall, thepreviously extended elements can be and preferably are either heldstationary or pulled back proximally to prevent them from damaging bodytissues outside the aorta. It should also be mentioned that threadingsuch as 254, 244, 232, and 224 is entirely optional and can be omittedif the associated elements are made sharp enough and can be pusheddistally sufficiently strongly to penetrate the aorta wall without theaid of threading and rotation.

[0074] When the distal portion of catheter 210 is through the aortawall, distal balloon 214, which is now outside the aorta, is alsoinflated. The axial spacing between balloons 212 and 214 is preferablysmall enough so that the aorta wall is clamped between these twoballoons as shown in FIG. 9. For example, if balloons 212 and 214 wereinflated without the presence of the aorta wall, their appearance mightbe as shown in FIG. 10. The close spacing of balloons 212 and 214, aswell as their resilient bias toward one another, helps to anchorcatheter 210 through the aorta wall and also to seal the aorta wallaround the catheter. Balloons 212 and 214 may be inflated by liquid orgas, and they may be specially coated to help improve the seal betweencatheter 210 and the aorta wall.

[0075] After the condition of catheter 210 shown in FIG. 9 has beenreached, all of components 220, 230, 240, and 250 can be withdrawn fromthe patient by pulling them out of catheter 210 in the proximaldirection.

[0076] The next step in the illustrative procedure being described is toinsert an elongated, steerable, endoscopic instrument 300 lengthwiseinto catheter 210. A simplified cross sectional view of an illustrativesteerable endoscopic instrument 300 is shown in FIG. 11. As shown inthat FIG., instrument 300 includes one or more sheath structures such as310 a and 310 b that are operable by the physician to steer theinstrument by curvilinearly deflecting it laterally by a desired,variable amount. In lieu of or in addition to steering sheaths 310 a and310 b, any other conventional steering elements may be provided andused. Other examples of suitable steering structures are shown inBachinski et al. U.S. patent application Ser. No. 08/842,391, filed Apr.23, 1997 (published as WO 98/19732), which is hereby incorporated byreference herein. Within sheaths 310 are such other components as (1) afiber optic bundle 320 for conveying light from outside the patient tothe distal end of instrument 300 in order to provide illumination beyondthe distal end of the instrument, (2) another fiber optic bundle 330 forconveying an image from beyond the distal end of the instrument back tooptical and/or video equipment outside the patient and usable by thephysician to see what is beyond the distal end of the instrument, and(3) a lumen 340 with a longitudinal structure 150 (i.e., a wire) insideof it. Additional lumens such as 360 may be provided for such purposesas (1) introducing fluid that may help to clear the distal ends of fiberoptic bundles 320 and 330, (2) introducing fluid for irrigating and/ormedicating the patient, (3) suctioning fluid from the patient, etc.

[0077] As shown in FIG. 12, the distal portion of steerable endoscopicinstrument 300 is extended distally beyond the distal end of catheter210 and steered by the physician until it is adjacent to the exterior ofcoronary artery portion 24. The endoscopic features of instrument 300are used by the physician to help steer the distal end of the instrumentto the desired location. Instrument 300 may also be provided withradiologic markers (like markers 206 on instrument 200 in FIG. 1) toadditionally help the physician get the distal end of instrument 300 tothe desired location.

[0078] The next step in the illustrative procedure being described is toextend longitudinal structure 150 from the distal end of instrument 300so that it passes through the wall of coronary artery 20 at location 24and into the lumen of the artery as shown in FIG. 13. To facilitatepenetration of the coronary artery wall, the distal end of longitudinalstructure 150 may be sharply pointed. The distal portion of longitudinalstructure 150 may also be threaded (analogous to the threads 254 shownon the distal portion of longitudinal structure 250 in FIG. 8) andlongitudinal structure 150 may be rotated about its longitudinal axis sothat the threads engage the coronary artery wall tissue and pulllongitudinal structure 150 into and through the coronary artery wall.The distal portion of longitudinal structure 150 is preferably pushedsufficiently far down into the lumen of coronary artery 20 so that itdoes not inadvertently come out of the coronary artery.

[0079]FIG. 13a shows alternative apparatus that may be used to introducethe distal portion of longitudinal structure 150 into coronary artery 20at location 24. This apparatus includes a hypotube 370 that extendsdistally from the distal end of instrument 300. Hypotube 370 may have afixed amount of extension from instrument 300, or it may be selectivelyextendable from instrument 300. Hypotube 370 has a sharply pointeddistal tip portion 372, the purpose of which will be described below. Anillustrative size for hypotube 370 is about 0.015 inches in diameter.

[0080] Longitudinal structure 150 is disposed coaxially inside hypotube370 and is axially and rotatably movable relative to hypotube 370. Theproximal portion 150 a of structure 150 may be a wire having a diameterof about 0.009 inches. A distal portion 150 b of wire 150 a may beground down to produce a safety ribbon inside wire coil 150 c. Anillustrative size for the wire of coil 150 c is about 2 mils. Theproximal end of coil wire 150 c is secured to wire 150 a. The distal endof coil wire 150 c is secured to distal tip 150 d, which is also securedto the distal end of safety ribbon 150 b. Elements 150 b, 150 c, and 150d cooperate to give longitudinal structure 150 a highly flexible distalportion.

[0081] Prior to use of sharply pointed cutter tip 372 as describedbelow, the distal portion of longitudinal structure 150 may be distallyextended from the distal portion of hypotube 370. This protects cuttertip 372 and also protects nearby tissue from the cutter tip.

[0082] Instrument 300 is controlled as described above in connectionwith FIG. 12 to position cutter tip 372 adjacent coronary artery portion24. Longitudinal structure 150 is then retracted proximally to exposecutter tip 372. Next, cutter tip 372 is advanced to make a slit throughcoronary artery portion 24. With cutter tip 372 still in this slit,longitudinal structure 150 is moved distally relative to hypotube 370 sothat the distal portion of structure 150 passes through theabove-mentioned slit into the lumen of coronary artery 20. Once insidethe coronary artery lumen, the distal portion of longitudinal structure150 can be pushed farther down along that lumen. Wire coil 150 c can beused to threadedly engage the interior of the coronary artery where thecoronary artery narrows down (farther along its length) to helpreleasably anchor the distal portion of structure 150 in the coronaryartery. This threaded engagement can be produced by rotatinglongitudinal structure 150 about its longitudinal axis when thelongitudinal structure begins to encounter resistance to further distalpushing along the coronary artery. Of course, this threaded engagementis reversible by rotating longitudinal structure 150 in the directionopposite to the direction which produces the threaded engagement.

[0083] After the distal portion of longitudinal structure 150 issatisfactorily in place in the lumen of coronary artery 20 as describedabove in connection with FIG. 13 and/or FIG. 13a, the next step is towithdraw instrument 300 (including hypotube 370 if provided) from thepatient by pulling instrument 300 back out through catheter 210. Onlylongitudinal structure 150 from instrument 300 is left in the patient asshown in FIG. 14. If desired, longitudinal structure 150 may be providedwith radiologic markers 154 equally spaced along the length of itsdistal portion to help the physician determine by radiologic observationthe actual length between location 24 and location 34. This enables thephysician to determine the exact length of the graft tubing needed toconnect locations 24 and 34.

[0084] The next phase of the illustrative procedure being described isto install a new length of tubing between regions 24 and 34. The newlength of tubing may be either an artificial graft, natural body organtubing harvested from the patient's body, or a combination of artificialand natural tubing (e.g., natural tubing coaxially inside artificialtubing). In the following discussion it is assumed that the new tubingis to be natural tubing (e.g., a length of the patient's saphenous veinthat has been harvested for this purpose) inside an artificial conduit.When such a combination of natural and artificial conduits is used, bothconduits can be delivered and installed simultaneously, or the outerartificial conduit can be delivered and installed first, and then theinner natural conduit can be delivered and installed. The followingdiscussion initially assumes that the latter technique is employed.

[0085] In accordance with the above-stated assumptions, the next step inthe procedure is to use catheter 210 and longitudinal structure 150(hereinafter referred to for convenience and simplicity of terminologyas wire 150) to deliver an artificial conduit so that it extends betweenregions 24 and 34. The distal portion of an illustrative assembly 400for doing this is shown in FIG. 15. (Several alternative constructionsof this portion of the apparatus are shown in later FIGS. and describedbelow.) As shown in FIG. 15 assembly 400 includes a threaded, conical,distal tip 412 mounted on a tubular member 410 (e.g., metal hypotube)through which wire 150 can freely pass. Additional details regardingvarious possible constructions of tip 412 are provided later withreference to FIGS. 15a-15 g, but it should be mentioned here that inthis embodiment tip 412 is selectively collapsible to facilitate itswithdrawal from the patient after it has served its purpose. Anothertubular member 420 is disposed concentrically around tubular member 410.An inflatable balloon 422 is mounted on the distal end of tubular member420. Tubular member 420 includes an axially extending lumen (not shownin FIG. 15) for use in selectively inflating and deflating balloon 422.Balloon 422 is shown deflated in FIG. 15.

[0086] Coaxially around tubular member 420 is an artificial graftconduit 430. An illustrative embodiment of a suitable conduit 430 isshown in FIG. 16 and includes a tube formed of a frame 432 of a firsthighly elastic material (such as nitinol) with a covering 434 of asecond highly elastic material (e.g., a rubber-like material such assilicone) substantially filling the apertures in the frame. Additionalinformation regarding this possible embodiment of conduit 430 and othersuitable artificial graft structures is provided in the Goldsteen et al.reference which is first mentioned above (see also Bachinski et al. U.S.patent application Ser. No. 08/839,080, filed Apr. 23, 1997 (publishedas WO 98/19632), which is also hereby incorporated by reference herein).Here it will suffice to say that this structure is extremely elastic,flexible, pliable, and resilient. For example, it can be stretched to asmall fraction of its original diameter, and it thereafter returns byitself to its original size and shape without damage or permanentdeformation of any kind. In addition, this structure is distensible sothat it may pulsate very much like natural circulatory system tubing inresponse to pressure waves in the blood flow. This helps keep theconduit open, especially if it is used by itself as the final graftconduit. At its distal end, extensions of frame 432 are flared out toform resilient hooks or barbs 436, the purpose of which will becomeapparent as the description proceeds. Near the proximal end of conduit430 two axially spaced resilient flaps 438 a and 438 b with hooks orbarbs 439 are provided. The purpose and operation of elements 438 and439 will also become apparent as the description proceeds.

[0087] In assembly 400 (see again FIG. 15, and also FIG. 17), hooks 436and flaps 438 are compressed radially inwardly and confined withinconduit delivery tube 440, which coaxially surrounds conduit 430.Indeed, conduit 430 may be somewhat circumferentially compressed by tube440.

[0088] The portion of assembly 440 at which the proximal end of conduit430 is located is shown in FIG. 17. There it will be seen how flaps 438are confined within conduit delivery tube 440. FIG. 17 also shows howtubes 410, 420, and 440 extend proximally (to the right as viewed inFIG. 17) from the proximal end of conduit 430 so that the physician canremotely control the distal portion of assembly 400 from outside thepatient.

[0089] To install artificial graft conduit 430 in the patient betweenregions 24 and 34, assembly 400 is fed into the patient along wire 150through catheter 210. When tip 412 reaches coronary artery portion 24,tip 412 is threaded into and through the coronary artery wall byrotating tube 410 and therefore tip 412. The passage of tip 412 throughthe coronary artery wall opens up the aperture previously made by wire150 in that wall. After tip 412 passes through the artery wall, thatwall seals itself against the outside of the distal portion of conduitdelivery tube 440 as shown in FIG. 18.

[0090] The next step is to push tube 410 and tip 412 distally relativeto delivery tube 440, which is held stationary. Conduit 430 is initiallymoved distally with components 410 and 412. This may be done byinflating balloon 422 so that it engages conduit 430, and then movingtube 420 distally with components 410 and 412. Distal motion of conduit430 moves hooks 436 beyond the distal end of delivery tube 440, therebyallowing the hooks to spring out inside coronary artery 20 as shown inFIG. 19. This prevents the distal end of conduit 430 from being pulledproximally out of the coronary artery. If balloon 422 was inflatedduring this phase of the procedure, it may be deflated before beginningthe next phase.

[0091] The next step is to pull delivery tube 440 back slightly so thatit is withdrawn from coronary artery 20. Then tube 420 is moved distallyso that balloon 422 is radially inside the annulus of hooks 436. Balloon442 is then inflated to ensure that hooks 436 are firmly set in coronaryartery 20. Conditions are now as shown in FIG. 20. Cross sections ofballoon 422 may be L-shaped when inflated (one leg of the L extendingparallel to the longitudinal axis of conduit 430, and the other leg ofthe L extending radially outward from that longitudinal axis immediatelydistal of hooks 436). This may further help to ensure that hooks 436fully engage the wall of coronary artery 20.

[0092] The next step is to deflate balloon 422. Then delivery tube 440is withdrawn proximally until flap 438 a (but not flap 438 b) is distalof the distal end of the delivery tube. This allows flap 438 a to springradially out as shown in FIG. 21. Tube 420 is then withdrawn untilballoon 422 is just distal of flap 438 a. Then balloon 422 is inflated,producing the condition shown in FIG. 21.

[0093] The next steps are (1) to deflate distal balloon 214, (2) toproximally withdraw catheter 210 a short way, (3) to proximally withdrawtube 420 to press flap 438 a against the outer surface of the aortawall, and (4) to proximally withdraw delivery tube 440 by the amountrequired to allow flap 438 b to spring out against the interior ofcatheter 210, all as shown in FIG. 22. As a result of theabove-described proximal withdrawal of tube 420, the hooks or barbs 439on flap 438 a are urged to enter the aorta wall tissue to help maintainengagement between flap 438 a and the wall of the aorta. Inflatedballoon 422 helps to set hooks or barbs 439 in the tissue when tube 420is tugged proximally.

[0094] The next step is to insert the distal portion of delivery tube440 into the proximal end of conduit 430 as shown in FIG. 22a. Thedistal end of conduit 440 may be inserted all the way to the proximalend of balloon 422 (see FIG. 23 for a depiction of this). A purpose ofthis step is to subsequently help control the rate at which blood isallowed to begin to flow through conduit 430.

[0095] The next step is to proximally withdraw catheter 210 by theamount required to release flap 438 b to spring out against the interiorof the wall of aorta 30 as shown in FIG. 22b. Catheter 210 may besubsequently pushed back against flap 438 b as shown in FIG. 23 to helpsecurely engage that flap against the aorta wall.

[0096] Artificial graft conduit 430 is now fully established betweenaorta region 34 and coronary artery region 24. The next steps aretherefore to deflate balloon 422 and proximally withdraw tube 420, tocollapse tip 412 and proximally withdraw tube 410, and to proximallywithdraw delivery tube 440. The proximal end of conduit 430 is now asshown in FIG. 24. As possible alternatives to what is shown in FIG. 24,the distal end of catheter 210 could be left pressed up against proximalflap 438 b and/or the distal portion of delivery tube 440 could be leftinside the proximal portion of conduit 430. If the latter possibility isemployed, then delivery of the natural graft conduit (described below)can be through tube 440.

[0097] Several illustrative embodiments of collapsible tips 412 areshown in FIGS. 15a-15 g. In the first embodiment (shown in FIGS. 15a-15c) a frame of wire struts 412 a extends radially out and proximally backfrom the distal end of hypotube 410 (see especially FIG. 15a). Thisframe is covered with a somewhat elastic polymer cover 412 b (FIG. 15b)which is provided with threads as indicated at 412 c. For example,threads 412 c may be made of one or more spirals of nitinol wire orother metal. When it is desired to collapse tip 412, another hypotube410 a (which is disposed around hypotube 410) is shifted distallyrelative to hypotube 410 to invert and collapse tip 412 as shown in FIG.15c.

[0098] In the alternative embodiment shown in FIGS. 15d and 15 e, tip412 has a central main portion 412 e attached to hypotube 410. Aroundthe proximal portion of main portion 412 e are a plurality of triangularshaped portions 412 f, each of which is connected to main portion 412 eby a hinge 412 g. The outer surface of the tip is threaded as indicatedat 412 h. For example, in this embodiment tip 412 may be made of aplastic polymer material, and hinges 412 g may be so-called “living”hinges between the various masses of the polymer. As soon as triangularportions 412 f meet any resistance as tip 412 is withdrawn proximally,they pivot about their hinges 412 g to the positions shown in FIG. 15e,thereby greatly reducing the circumferential size of the tip.

[0099] In the further alternative embodiment shown in FIGS. 15f and 15g, metal struts 412 j are attached to the distal end of hypotube 410 sothat they extend radially out and proximally back. Although not shown inFIGS. 15f and 15 g, struts 412 j are covered with a cover and threadslike the cover 412 b and threads 412 c shown in FIG. 15b and describedabove. A wire 412 k connects a proximal portion of each strut 412 j,through an aperture in hypotube 410, to the distal end of anotherhypotube 410 b which is disposed inside hypotube 410. When wires 412 kare relaxed as shown in FIG. 15f, struts 412 j extend radially outbeyond the circumference of delivery tube 440. When it is desired tocollapse tip 412, hypotube 410 b is pulled back proximally relative tohypotube 410 as shown in FIG. 15g. This causes wires 412 k to pullstruts 412 j in so that the outer circumference of tip 412 is muchsmaller than the circumference of delivery tube 440.

[0100] Again, it should be mentioned that the use of a threaded,collapsible tip 412 as described above is only one of severalpossibilities. Other alternatives are discussed below after completionof the discussion of the illustrative procedure which is being describedand which will now be further considered with reference to FIG. 25 andsubsequent FIGS.

[0101] As has been mentioned, the illustrative procedure being describedassumes that natural body conduit (e.g. a length of the patient'ssaphenous vein that has been harvested for this purpose) is installedinside artificial conduit 430 after installation of the latter conduit.An illustrative assembly 500 for delivering a length of natural bodyconduit to installed conduit 430 is shown in FIG. 25.

[0102] As shown in FIG. 25, assembly 500 includes a tube 510 disposedaround wire 150 so that tube 510 is freely movable in either directionalong wire 150. Tube 510 has an inflatable annular balloon 512 a nearits distal end and another inflatable annular balloon 512 b spaced inthe proximal direction from balloon 512 a. Tube 510 includes separateinflation lumens (not shown) for each of balloons 512 so that theballoons can be separately inflated and deflated. An annular collarstructure or ring 520 a is disposed concentrically around balloon 512 a,and a similar annular collar structure or ring 520 b is disposedconcentrically around balloon 512 b. Balloons 512 may be partlyinflated. Each of rings 520 may have radially outwardly extending hooksor barbs 522. A length of natural body conduit 530 (e.g., saphenous veinas mentioned earlier) extends from ring 520 a to ring 520 b around theintervening portion of tube 510. Hooks or barbs 522 may extend throughthe portions of conduit 530 that axially overlap rings 520. A deliverytube 540 is disposed around conduit 530. In use, tubes 510 and 540extend proximally (to the right as viewed in FIG. 25) out of the patientto permit the physician to remotely control the distal portion ofassembly 500.

[0103] Although not shown in FIG. 25, assembly 500 may include a springcoil (similar to coil 450 in FIG. 36) extending between rings 520 insideof conduit 530 to help hold conduit 530 open and out against deliverytube 540 or subsequently out against conduit 430. Instead of balloons512 being both in the same tube 510, balloon 512 a may be on arelatively small first tube, while balloon 512 b is on a larger secondtube that concentrically surrounds the proximal portion of the firsttube. The first and second tubes are axially movable relative to oneanother, thereby allowing the distance between balloons 512 to beadjusted for grafts 530 of different lengths. Illustrative apparatus ofthis kind is shown in Goldsteen et al. U.S. Pat. No. 5,931,842, which ishereby incorporated by reference herein.

[0104] Assembly 500 is employed by placing it on wire 150 leading intocatheter 210. Assembly 500 is then advanced distally along wire 150through catheter 210 and then into conduit 430 until the distal end ofconduit 530 is adjacent the distal end of conduit 430 and the proximalend of conduit 530 is adjacent the proximal end of conduit 430. Thecondition of the apparatus at the distal end of assembly 500 is now asshown in FIG. 26. The condition of the apparatus at the proximal end ofconduit 530 is as shown in FIG. 28.

[0105] The next step is to proximally withdraw delivery tube 540 so thatthe distal portion of conduit 530 and distal barbed ring 520 a are nolonger inside the distal portion of delivery tube 540. Then distalballoon 512 a is inflated to circumferentially expand ring 520 a and toset hooks or barbs 522 through conduit 530 into the surrounding portionof conduit 430 and coronary artery wall portion 24. This provides acompleted anastomosis of the distal end of conduit 530 to coronaryartery 20. FIG. 27 shows the condition of the apparatus at this stage inthe procedure.

[0106] The next step is to continue to proximally withdraw delivery tube540 until the proximal end of conduit 530 and proximal ring 520 b are nolonger inside tube 540 (see FIG. 29). Then proximal balloon 512 b isinflated to circumferentially expand ring 520 b and thereby set hooks orbarbs 522 through conduit 530 into the surrounding portion of conduit430 and aorta wall portion 34 (see FIG. 30). This provides a completedanastomosis of the proximal end of conduit 530 to aorta 30.

[0107] The next step is to deflate balloons 512 a and 512 b andproximally withdraw tube 510 and delivery tube 540 from the patient viacatheter 210. Then wire 150 is withdrawn from the patient by pulling itproximally from catheter 210. Lastly, catheter 210 is proximallywithdrawn from the patient to conclude the procedure. The bypass that isleft in the patient is as shown in FIG. 31. This bypass extends fromaorta 30 at location 34 to coronary artery 20 at location 24. The bypassincludes natural body conduit 530 inside artificial graft conduit 430.One end of the bypass is anchored and anastomosed to coronary artery 20by hooks 436 and ring 520 a. The other end of the bypass is anchored andanastomosed to aorta 30 by flaps 438 and ring 520 b.

[0108] The particular uses of the invention that have been described indetail above are only illustrative of many possible uses of theinvention. Other examples include same-vessel bypasses in the coronaryarea and vessel-to-vessel and same-vessel bypasses in other portions ofthe circulatory system (including neurological areas, renal areas,urological areas, gynecological areas, and peripheral areas generally).A same-vessel bypass is a bypass that extends from one portion of avessel to another axially spaced portion of the same vessel. In FIG. 32,bypass 620 is a same-vessel bypass around a narrowing 612 in vessel 610.For ease of comparison to previously described embodiments, the variouscomponents of bypass 620 are identified using the same reference numbersthat are used for similar elements in FIG. 31. The invention is alsoapplicable to procedures similar to any of those mentioned above, butfor non-circulatory systems such as urological tubing.

[0109] It has been mentioned that the collapsible tip structures shown,for example, in FIGS. 15-15 g are illustrative of only one of severalpossible approaches to providing a structure that can penetrate the wallof coronary artery 20 from outside the artery. Another example of asuitable structure is shown in FIG. 33. To facilitate comparison to FIG.15, FIG. 33 uses reference numbers with primes for elements that aregenerally similar to elements identified by the corresponding unprimedreference numbers in FIG. 15.

[0110] In the embodiment shown in FIG. 33 distal tip 412′ has externalthreads 414 for helping to grip and dilate tissue such as the wall ofcoronary artery 20 as tip 412′ is rotated about wire 150 by rotation ofproximally extending tubular shaft 410′. Threads 414 continue as threads442 on the exterior of the distal portion of tube 440′. Threads 414 alsothreadedly engage with threads 444 on the interior of the distal portionof tube 440′. Thus when both of structures 410′ and 440′ are rotatedtogether, threads 414 and 442 tend to pull tip 412′ and then the distalportion of tube 440′ into and through the wall of coronary artery 20. Inthe course of this, threads 412′ transfer the tissue to threads 442.Thereafter, structure 410′ can be removed from structure 440′ byrotating structure 410′ in the direction relative to structure 440′ thatcauses threads 414 and 444 to cooperate to shift tip 412′ proximallyrelative to structure 440′. When tip 412′ has thus shifted proximallybeyond threads 444, elements 410′ and 412′ can be pulled proximally outof the patient. Tube 440′, which remains in place through the coronaryartery wall, can thereafter be used as a guide tube for delivery of agraft structure (such as 430 (FIGS. 15-17)) and associatedinstrumentation (such as structure 420 (e.g., FIGS. 15 and 17)) to theoperative site.

[0111] Another illustrative alternative embodiment of some of theinstrumentation shown in FIG. 15 is shown in FIGS. 34 and 35. Onceagain, to facilitate comparison to FIG. 15, FIGS. 34 and 35 usereference numbers with primes for elements that are generally similar toelements identified by the corresponding unprimed reference numbers inFIG. 15. In the embodiment shown in FIGS. 34 and 35 struts 436′ areconnected to the distal end of a serpentine ring 439 which is connectedin turn to the distal end of frame 432′. Struts 436′ are initially heldin the form of a distally pointed cone by yieldable bands 437 a, 437 b,437 c, and 437 d. As elsewhere along graft conduit 430′, the spacesbetween struts 436′ are substantially filled by a highly elasticmaterial such as silicone rubber. Bands 437 may be made of a polymericor other suitable yieldable material. Alternatively, bands 437 could beserpentine metal members that yield by becoming straighter. Bands 437are initially strong enough to prevent struts 436′ from flaring radiallyoutward from conduit 430′ as the struts are resiliently biased to do.However, bands 437 can be made to yield by inflating balloon 422′ (onthe distal end of tube 420′) inside the annulus of struts 436′.

[0112] Struts 436′ can be forced through tissue such as the wall ofcoronary artery 20 in their initial cone shape. Sufficient pushing forcecan be applied to the cone of struts 436′ in any of several ways. Forexample, tube 420′ may be metal (e.g., stainless steel) hypotube whichcan transmit pushing force to the cone of struts 436′ by inflatingballoon 422′ to trap the base of the cone between balloon 422′ and tube440. Additional pushing force may then also be applied via tube 440itself.

[0113] When a sufficient portion of the height of the cone of struts436′ is through the coronary artery wall, balloon 422′ is inflatedinside the cone as shown in FIG. 35 to cause bands 437 to yield. Thisallows struts 436′ to flare radially outward inside the coronary artery,thereby anchoring the distal end of conduit 430′ to the artery. Bands437 may be made progressively weaker in the distal direction tofacilitate prompt yielding of distal bands such as 437 a and 437 b inresponse to relatively little inflation of balloon 422′, whereas moreproximal bands such as 437 c and 437 d do not yield until somewhat laterin response to greater inflation of balloon 422′. This progression ofyielding may help ensure that the annulus of struts flares out in thedesired trumpet-bell shape of hooks inside the coronary artery.

[0114]FIGS. 34 and 35 illustrate the point that if the structure used toenlarge the initial hole (made by wire 150) through the wall of coronaryartery 20 is sufficiently sharp, it may not be necessary to providethreads on and rotation of the structure. Instead, the hole-enlargingstructure can simply be pushed through the coronary artery wall. Thissame principle applies to all embodiments of structures for penetratingthe coronary artery wall and subsequently enlarging the opening in thatwall (e.g., as in FIGS. 13, 15-15 g, 33, and 36-39).

[0115]FIGS. 36 and 37 illustrate another possible use of a conestructure like that shown in FIGS. 34 and 35, as well as illustratingother possible aspects of the invention. These FIGS. illustrate astructure that can be used to deliver an artificial graft conduit, or anatural graft conduit, or both an artificial graft conduit and a naturalgraft conduit simultaneously (e.g., with the natural conduit coaxiallyinside the artificial conduit). In the particular case shown in FIGS. 36and 37 it is assumed that only natural graft conduit is being delivered,but it will be readily apparent that artificial graft conduit could besubstituted for or added outside the natural graft conduit.

[0116] In the embodiment shown in FIGS. 36 and 37 the cone of struts436′ is mounted on the distal end of a highly elastic coil spring 450.The proximal end of coil 450 is attached to ring 460. The cone of barbs436′ is provided with additional, relatively short, radially outwardlyprojecting hooks or barbs 436″ near the proximal base of the cone. Asshown in FIG. 37, hooks or barbs 436″ extend into and/or through thedistal portion of a length of graft tubing 530, which (as has beenmentioned) is assumed in this case to be natural body organ tubing suchas saphenous vein. Ring 460 is similarly provided with radiallyoutwardly extending hooks or barbs 462 which extend into and/or throughthe proximal portion of graft conduit 530. Ring 460 also includesresilient radially outwardly extending annular flaps 438 a and 438 bwith hooks or barbs 439, all similar to correspondingly numberedelements in FIG. 16. Spring 450, which is inside conduit 530 between thecone of barbs 436′ and ring 460, helps to support and hold open thegraft conduit. Structure 420′ (similar to structure 420′ in FIGS. 34 and35 and including balloon 422′ as shown in those FIGS.) is disposedaround wire 150 inside structures 436′, 450, 460, and 530. Delivery tube440 is disposed around conduit 530.

[0117] The embodiment shown in FIGS. 36 and 37 illustrates a structurewhich can be used to deliver and install natural body organ conduitwithout any full length artificial graft conduit being used. In a mannersimilar to what is shown in FIGS. 34 and 35, the structure shown in FIG.37 is delivered to the operative site via wire 150. The cone of struts436′ is forced through the wall of coronary artery 20 and then flaredradially outward inside the coronary artery to anchor the distal end ofthe graft conduit to that artery. The distal end of delivery tube 440 ispulled back as needed to aid in attachment of the distal end of thegraft structure. Attachment of the proximal end of the graft structureto the wall of aorta 30 is performed similarly to what is shown in FIGS.21-24. Accordingly, with distal flap 438 a just outside the wall ofaorta 30, delivery tube 440 is pulled back proximally to expose thatflap. Flap 438 a is thereby released to spring out and engage the outersurface of the aorta wall. After that has occurred, proximal flap 438 bis adjacent the inner surface of the aorta wall. Tube 440 is pulled backproximally even farther to expose flap 438 b so that it can spring outand engage the inner surface of the aorta wall. Natural body organ graft530 is now fully installed in the patient. Structures 436′, 450, and 460remain in place in the patient to help anchor the ends of graft conduit530 and to help hold open the medial portion of that conduit.

[0118] In embodiments like FIGS. 36 and 37, coil 450 is optional. Ifcoil 450 is used, its ends may or may not be attached to structures 436and/or 460.

[0119] A coil like coil 450 can be used in other embodiments of theinvention. For example, a coil like 450 could be used between rings 520a and 520 b in embodiments like that shown in FIG. 25 to help hold opengraft conduit 530 in that embodiment.

[0120] Still another illustrative alternative embodiment of some of theinstrumentation shown in FIG. 15 is shown in FIG. 38. To facilitatecomparison to FIG. 15, FIG. 38 uses reference numbers with double primesfor elements that are generally similar to elements identified by thecorresponding unprimed reference numbers in FIG. 15. In the embodimentshown in FIG. 38, the distal end of artificial graft conduit 430″ isattached to expandable ring 430 a. Elongated struts 436″ extend distallyfrom the distal end of ring 430 a. The distal ends of struts 436″ areturned back in the proximal direction and extend just far enough intothe distal end of tube 420″ to be releasably retained by that tube.Struts 436″ are resiliently biased to extend radially outward from ring430 a, but are initially restrained from doing so by the presence oftheir distal end portions in the distal end of tube 420″. Thus struts436″ initially form a distally pointing cone that can be pushed throughtissue such as the wall of coronary artery 20 in the same manner thathas been described above in connection with FIGS. 34-37. Structure 420″,which may be metal (e.g., stainless steel) hypotube with an inflatableannular balloon 422″ near its distal end, may be used to help push thecone through the tissue.

[0121] After the distal portion of the cone of struts 436″ has beenpushed through the wall of coronary artery 20, tube 420″ is shiftedproximally relative to the struts to release the distal end portions ofthe struts. This allows struts 436″ to spring radially outward from ring430 a inside coronary artery 20, thereby anchoring the distal end of thegraft conduit in the coronary artery. Ring 430 a can then becircumferentially expanded to increase the size of the connectionbetween coronary artery 20 and the distal portion of the graft conduit.If desired, each of struts 436″ may be twisted 180° as shown in FIG. 39before it enters the distal end of tube 420″. This promotes turning ofthe extreme distal end portions of the struts toward the coronary arterywall when the struts are released from tube 420″.

[0122] Ring 430 a and struts 436″ may be made of any suitable materialsuch as any 300-series stainless steel (e.g., 316L stainless steel).Another material that may be suitable for struts 436″ is nitinol. As inpreviously described embodiments, the elastic cover 434 that forms partof conduit 430″ preferably extends to regions 430 a and 436″.

[0123] The structures shown herein and described above for penetratingexisting body organ tissues and for connecting and/or fastening graftstructures to existing body organ tissues are only illustrative ofstructures that can be used. Other examples of such structures are shownin Bachinski et al. U.S. Pat. No. 6,036,702, which is herebyincorporated by reference herein.

[0124] Although it has been said that it is not necessary in accordancewith and for purposes of this invention to intralumenally approach morethan one end of the graft site, it is not inconsistent with thisinvention to also use other instrumentation to intralumenally approachthe other end of the graft site. For example, it may be desirable tointroduce a catheter into coronary artery 20 during the proceduredescribed above that includes FIG. 1 and related FIGS. in order tomedicate the coronary artery, to introduce radiologic (e.g.,fluroscopic) liquids into the coronary artery, etc.

[0125]FIG. 40 shows a structure 700 that may be used as an alternativeto an inflatable balloon for radially enlarging a surrounding structuresuch as a connector between a natural or artificial graft and apatient's body tissue. For example, structures like structure 700 may beused in place of one or more of balloons 422 (FIGS. 15 and 18-23), 512a/512 b (FIGS. 25-30), 422′ (FIG. 35), or 422″ (FIG. 38), or whereverelse a generally similar radially enlargeable structure is needed.

[0126] Structure 700 includes an outer tube 710 (e.g., of metalhypotube). Near the distal end of tube 710 pivotable members 720 a and720 b are pivotally mounted on a pin 730 which extends transverselyacross tube 710. The proximal portions of members 710 a and 710 b arepivotally connected to links 740 a and 740 b, respectively. The proximalends of links 740 are pivotally connected to the distal end of wire 750.Axially extending slots 760 are formed in diametrically opposite sidesof tube 710 to allow members 720 and 740 to extend radially out of tube710, for example, as shown in FIG. 40. The distal ends of members 720can be brought together by pulling wire 750 proximally relative to tube710. Alternatively, that portion of structure 700 can be radiallyenlarged (i.e., the distal portions of members 720 can be spread apart)by pushing wire 750 distally relative to tube 710. Structure 700 istherefore another example of a selectively radially enlargeablestructure that can be used in accordance with this invention.

[0127] If desired, one or more selectively inflatable balloons 780 maybe disposed on structure 700. Each such balloon 780 preferably extendsannularly around structure 700. (For greater clarity FIG. 40 only showsthe rear half of annular balloon 780.) Balloon 780 and/or similarballoons may be used for such purposes as helping to hold a graft inposition around structure 700 during use of structure 700 to transportthe graft. Balloon 780 or like balloons may be selectively inflated viaan inflation lumen which extends proximally from the balloon alongcomponent 710.

[0128] As an alternative to pushing wire 750 to spread the distalportions of members 720 apart, links 740 can start out more nearlypartly overlapping the proximal portions of members 720. Then when wire750 is pulled proximally relative to tube 710, the distal portions ofmembers 720 will be spread apart.

[0129] It will be understood that the foregoing is only illustrative ofthe principles of the invention, and that various modifications can bemade by those skilled in the art without departing from the scope andspirit of the invention. For example, the order of some steps in theprocedures that have been described are not critical and can be changedif desired. The manner in which radiologic elements and techniques areused for observation of the apparatus inside the patient may vary. Forexample, radiologic fluids may be injected into the patient throughvarious lumens in the apparatus to help monitor the location of variousapparatus components in the patient, and/or radiologic markers (of whichthe above-described markers such as 154 and 206 are examples) may beprovided anywhere on the apparatus that may be helpful to the physician.

The Invention claimed is:
 1. Apparatus for radially enlarging astructure used in a medical procedure comprising: a first elongatedcomponent having axially spaced proximal and distal portions; first andsecond members mounted for radial movement relative to the distalportion of the first component, the first and second members beingmovable along respective different radii of the first component; and asecond elongated component substantially parallel to the firstcomponent, the second component being operatively connected to the firstand second members and movable relative to the first component toproduce the radial movement of the first and second members.
 2. Theapparatus defined in claim 1 further comprising: a selectivelyinflatable balloon on the distal portion of the first component.
 3. Theapparatus defined in claim 2 wherein the balloon extends annularlyaround the distal portion of the first component.
 4. The apparatusdefined in claim 1 wherein the first and second members are pivotallymounted on the distal portion of the first component.
 5. The apparatusdefined in claim 4 wherein the pivotal axis of each of the first andsecond members is transverse to the longitudinal axis of the firstcomponent.
 6. The apparatus defined in claim 1 wherein the secondcomponent is longitudinally movable relative to the first component toproduce the radial movement of the first and second members.
 7. Theapparatus defined in claim 1 wherein the first and second components aresubstantially concentric with one another.
 8. The apparatus defined inclaim 1 further comprising: first and second links operatively connectedbetween the second component and the first and second members,respectively.
 9. The apparatus defined in claim 8 wherein each of thefirst and second links is pivotally connected to the second componentand to the respective first or second member.
 10. The apparatus definedin claim 1 wherein the first component comprises a tubular member. 11.The apparatus defined in claim 10 wherein the second component isdisposed substantially coaxially in the tubular member.
 12. Theapparatus defined in claim 11 wherein the second component comprises anelongated wire member.